FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 歌禮製藥有限公司 呈交日期： 2025年9月10日 第 3 頁 共 7 頁 v 1.3.0 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | | 是 | | | | 證券代號 (如上市) 01672 | 說明 | | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 事件 | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | 已 ...

Core Viewpoint - Dongwu Securities reports that Gilead Sciences-B (01672) is progressing well with its pipeline for 2025, aligning with expectations, and the likelihood of successful product launches is high [1] Group 1: ASC30 Injection Data - The ASC30 injection has shown a promising apparent half-life of 75 days in obese subjects, indicating the potential for a quarterly dosing regimen for long-term weight management [1] - In the Phase Ib clinical study, no serious adverse events (SAEs) were reported, and only mild gastrointestinal-related adverse events (AEs) were observed, indicating excellent safety and tolerability for long-term use [2] Group 2: ULAP Platform and Future Developments - ASC30 is developed using Gilead's Ultra-Long-Acting Platform (ULAP), which allows for the creation of various long-acting formulations to meet diverse clinical needs [3] - The company is currently conducting a Phase IIa clinical trial for ASC30 in the U.S., utilizing the ULAP technology to achieve precise drug release and improve clinical efficacy [3] Group 3: Upcoming Catalysts and Clinical Data - The company expects to disclose significant clinical data in the second half of the year, including top-line results for ASC30 oral Phase II, ASC47 Phase I, and ASC50 Phase I in Q4 2025, and ASC30 subcutaneous Phase II in Q1 2026 [4] - Additionally, the company plans to submit 2-3 new IND applications to the FDA within the next 6-9 months, including a dual-target peptide weight loss pipeline [4]

Core Viewpoint - Dongwu Securities reports that Gilead Sciences-B (01672) is progressing well with its pipeline for 2025, aligning with the firm's expectations, and anticipates a high probability of successful product launches in the future [1] Group 1: ASC30 Injection Data - The ASC30 injection has shown a promising apparent half-life of 75 days in obese subjects, indicating the potential for a quarterly dosing regimen for long-term weight management [1] - In the Phase Ib clinical study, no serious adverse events (SAEs) were reported, and only mild gastrointestinal-related adverse events (AEs) were observed, indicating excellent safety and tolerability for long-term use [2] Group 2: ULAP Platform and Future Developments - ASC30 is developed using Gilead's Ultra-Long-Acting Platform (ULAP), which allows for the creation of various long-acting formulations to meet diverse clinical needs [3] - The company is currently conducting a Phase IIa clinical trial for ASC30 in the U.S., utilizing the ULAP technology to achieve precise drug release and improve clinical efficacy [3] Group 3: Upcoming Catalysts and Clinical Data - The company expects to disclose significant clinical data in the latter half of the year, including top-line results for ASC30 oral Phase II, ASC47 Phase I, and ASC50 Phase I in Q4 2025, and ASC30 subcutaneous Phase II in Q1 2026 [4] - Additionally, the company plans to submit 2-3 new IND applications to the FDA within the next 6-9 months, including a dual-target peptide weight management pipeline [4]

消息面上，歌礼制药宣布，小分子GLP-1受体(GLP-1R)激动剂ASC30用于减重维持的超长效皮下储库型 (depot)制剂在美国Ib期临床研究的肥胖受试者中显示出75天的表观半衰期，该数据支持ASC30作为长期 体重管理的维持疗法，每季度给药一次。ASC30减重维持制剂利用歌礼超长效药物开发平台开发而成。 东吴证券指出，公司下半年催化剂较多，多个重要临床数据即将披露：根据临床试验进度和公司公告， 预计2025年Q4将读出ASC30口服II期、ASC47的I期及ASC50的I期顶线数据，2026年Q1将读出ASC30皮 下注射II期顶线数据。同时公司预计未来6-9个月将向FDA申报2-3个新管线的IND，包含双靶点多肽减 重管线。 歌礼制药-B(01672)早盘涨超5%，截至发稿，涨5.02%，报14.86港元，成交额2036.04万港元。 ...

东吴证券指出，公司下半年催化剂较多，多个重要临床数据即将披露：根据临床试验进度和公司公告， 预计2025年Q4将读出ASC30口服II期、ASC47的I期及ASC50的I期顶线数据，2026年Q1将读出ASC30皮 下注射II期顶线数据。同时公司预计未来6-9个月将向FDA申报2-3个新管线的IND，包含双靶点多肽减 重管线。 智通财经APP获悉，歌礼制药-B(01672)早盘涨超5%，截至发稿，涨5.02%，报14.86港元，成交额 2036.04万港元。 消息面上，歌礼制药宣布，小分子GLP-1受体(GLP-1R)激动剂ASC30用于减重维持的超长效皮下储库型 (depot)制剂在美国Ib期临床研究的肥胖受试者中显示出75天的表观半衰期，该数据支持ASC30作为长期 体重管理的维持疗法，每季度给药一次。ASC30减重维持制剂利用歌礼超长效药物开发平台开发而成。 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The clinical data indicates an ultra-long half-life for ASC30, which is expected to be launched as a quarterly formulation [7] - ASC30 has shown a 75-day apparent half-life in obese subjects, suggesting the potential for a long-term weight management solution with quarterly dosing [7] - The safety data for ASC30 is excellent, with no serious adverse events reported, supporting the possibility of higher dosing [7] - The Ultra-Long-Acting Platform (ULAP) will facilitate the development of various subcutaneous injection formulations [7] - The company has multiple catalysts in the second half of the year, with important clinical data expected to be disclosed [7] - Revenue forecasts for 2025 are set at 0.02 billion, 0.64 billion, and 2.03 billion for 2025, 2026, and 2027 respectively, with a maintained "Buy" rating [7] Financial Summary - Total revenue for 2023 is projected at 56.69 million, with a significant increase expected in 2026 at 64.43 million and 203.23 million in 2027 [1][8] - The net profit attributable to the parent company is forecasted to be negative, with figures of (144.72) million in 2023 and (358.40) million in 2027 [1][8] - The earnings per share (EPS) is expected to improve from (0.15) in 2023 to (0.37) in 2027 [1][8] - The price-to-earnings (P/E) ratio is projected to decrease from (54.06) in 2023 to (21.83) in 2027 [1][8]

Core Insights - The announcement highlights the development of ASC30, a long-acting subcutaneous formulation of a small molecule GLP-1 receptor agonist, designed for weight maintenance therapy with a 75-day observed half-life, supporting quarterly dosing [1][2] Group 1: Clinical Research Findings - ASC30 demonstrated a median time to reach peak concentration (Cmax) of 17 days after a single 100 mg subcutaneous injection in obese subjects [1] - The drug showed a favorable gastrointestinal (GI) tolerance profile, with adverse events such as vomiting and nausea at 0.0%, and diarrhea and constipation at 12.5% in the ASC30 group, compared to higher rates in the placebo group [2] - No serious adverse events (SAE) or grade 3 and above adverse events (AE) were reported during the study, indicating a good safety profile [3] Group 2: Market Potential and Therapeutic Impact - ASC30 addresses a significant unmet medical need in long-term weight management, with the potential to improve patient adherence and quality of life through quarterly dosing [2] - The drug is positioned as a breakthrough in the field of weight maintenance therapy, being the fastest clinical advancement among quarterly dosing incretin medications [2] - ASC30 is the first and only small molecule GLP-1R agonist that can be administered orally daily or via subcutaneous injection monthly to quarterly, suitable for both weight loss and maintenance therapy [4]

Core Viewpoint - The announcement highlights the promising results of the small molecule GLP-1R agonist ASC30, which is being developed for weight maintenance therapy, showing a long apparent half-life of 75 days in obese subjects during a Phase Ib clinical trial [1] Group 1: Clinical Trial Results - ASC30 demonstrated an apparent half-life of 75 days in obese subjects, indicating its potential for long-term weight management [1] - After a single subcutaneous injection of 100 mg ASC30, the time to reach peak blood concentration (Cmax) was 17 days post-administration [1] - The blood concentration of ASC30 decreased to 50% of Cmax approximately 75 days after administration, supporting its quarterly dosing regimen [1] Group 2: Drug Development Potential - ASC30 is noted as the fastest progressing quarterly administered incretin drug in clinical development, suggesting a competitive edge in the market for weight management therapies [1] - The good tolerability of ASC30 supports its potential as a long-term maintenance therapy for weight management [1]

在Ib期研究中，未报告任何严重不良事件(SAE)，亦未观察到3级或以上不良事件(AE)。经100毫克 ASC30治疗的肥胖受试者中，GI相关AE较少且仅为1级。未出现肝酶(包括丙氨酸氨基转移酶(ALT)、天 冬氨酸氨基转移酶(AST)及总胆红素 (TBL))升高。实验室检查、生命体征、ECGs(心电图，包括按心率 校正的QT间期(QTc))和体格检查均未有异常。 ASC30超长效皮下注射储库型制剂展现出与剂量呈比例的药代动力学特征，可同时支持减重治疗和维持 疗法。同为利用歌礼ULAP开发的ASC30用于减重治疗的超长效皮下储库型制剂，作为每月一次减重治 疗疗法，目前正在美国开展IIa期研究 (NCT06679959)，受试者为肥胖人群(BMI ≥ 30 kg/m²)或伴有至少 一种体重相关合并症的超重人群(27 kg/m2 ≤ BMI < 30 kg/m2 )。预计于2026年第一季度获得 ASC30减重 治疗制剂IIa期研究的顶线数据。ASC30减重治疗制剂在肥胖受试者中表现出46天的表观半衰期，支持 每月给药一次治疗肥胖症。 基于小分子、多肽和蛋白质╱抗体的特性，歌礼可通过其专有的ULAP技术设计皮下储库 ...

ASC30是一款正在临床研究中的小分子GLP-1R偏向激动剂，具有独特和差异化性质，使得同一小分子 同时适用于口服片剂和皮下注射给药成为可能。ASC30是一种新化学实体(NCE)，拥有美国和全球化合 物专利保护，专利保护期至2044年(不含专利延期)。 8名肥胖受试者单次皮下注射ASC30减重维持制剂(100毫克)后，达到ASC30血药峰浓度(Cmax )的时间为 给药后17天(中位数)。给药约75天后，ASC30血药浓度降至Cmax值的百分五十(50%)，即表观半衰期为 75天。 格隆汇9月9日丨歌礼制药-B(01672.HK)公告，小分子GLP-1受体(GLP-1R)激动剂ASC30用于减重维持的 超长效皮下储库型(depot)制剂在美国Ib期临床研究(NCT06679959)的肥胖受试者(体重指数 (BMI)≥30kg/m)中显示出75天的表观半衰期(observedhalf-life)，该数据支持ASC30作为长期体重管理的维 持疗法，每季度给药一次。ASC30减重维持制剂利用歌礼超长效药物开发平台(Ultra-Long- ActingPlatform，ULAP)开发而成。 "减重维持疗法是长期体重管 ...